FDA Registration
Active
🇺🇸 United States
OCULUS, INC.
Reg #: 3033566
·
FEI: 3002785343
·
Expires 2026
Products
21
Proprietary Names
34
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- OCULUS, INC.
- Registration Number
- 3033566
- FEI Number
- 3002785343
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 17721 59th Avenue NE
- City
- Arlington
- State
- WA
- ZIP
- 98223
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202989
Owner / Operator
- Firm Name
- OCULUS OPTIKGERATE GMBH
- Operator Number
- 8010318
- Address
- Muenchholzhaeuser Str. 29, --
- City
- WETZLAR
- State
- DE-NOTA
- Postal Code
- D-35582
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device, Analysis, Anterior Segment | MXK | Class 2 | Ophthalmic | No | 2021-07-22 |
| Projector, Ophthalmic | HOS | Class 1 | Ophthalmic | No | 2023-09-26 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 1978-04-20 |
| Frame, Trial, Ophthalmic | HPA | Class 1 | Ophthalmic | No | 1978-04-20 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 1978-04-20 |
| Perimeter, Ac-Powered | HOO | Class 1 | Ophthalmic | No | 1978-04-20 |
| Perimeter, Automatic, Ac-Powered | HPT | Class 1 | Ophthalmic | No | 2000-07-11 |
| Tester, Color Vision | HIT | Class 1 | Ophthalmic | No | 2011-08-26 |
| Lens, Bagolini | HPD | Class 1 | Ophthalmic | No | 1978-04-20 |
| Anomaloscope | HIW | Class 1 | Ophthalmic | No | 2011-08-16 |
| Tomography, Optical Coherence | OBO | Class 2 | Ophthalmic | No | 2026-03-25 |
| Stereoscope, Ac-Powered | HJQ | Class 1 | Ophthalmic | No | 2013-09-07 |
| Pupillometer, Ac-Powered | HLG | Class 1 | Ophthalmic | No | 2016-09-05 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2013-08-27 |
| Biomicroscope, Slit-Lamp, Ac-Powered | HJO | Class 2 | Ophthalmic | No | 2020-11-06 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2013-09-07 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2020-11-09 |
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2000-07-11 |
| Exophthalmometer | HLS | Class 1 | Ophthalmic | No | 1978-04-20 |
| Tonometer, Ac-Powered | HKX | Class 2 | Ophthalmic | No | 2012-12-19 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 1978-04-20 |
Proprietary Names
Myopia Master
Easyfield VR
Set, Lens, Trial
Frame, Trial, Ophthalmic
Pentacam AXL
MAGNIFYING SPECTACLE
Easyfield C
Easyfield S
Smartfield
Centerfield 2
Twinfield 3
Perimeter
Color Vision Tester
C-Quant
Lens, Bagolini
Anomaloscope
Pentacam Cornea OCT
Binoptometer
Binoptometer 4P
Vissard 3D, Vissard MOBIL
Vissard RG
ImageCam 3
Pentacam AXL Wave
Pentacam
Pentacan HR
Hubtische
Ophthalmic table
LidStick
Keratograph 5M
Easygraph
Keratograph
Exophthalmometer
Corvis STL
Chart, Visual Acuity
Establishment Types
Complaint File Establishment per 21 CFR 820.198